2000966-386D
Dash™ 3000/4000/5000
CE-1
CE Marking Information
Compliance
The patient monitor bears CE mark CE-0459 indicating its conformity with the
provisions of the Council Directive 93/42/EEC concerning medical devices and
fulfills the essential requirements of Annex I of this directive. The product is in radio-
interference protection class A in accordance with EN 55011.
The country of manufacture can be found on the equipment labeling.
The product complies with the requirements of standard EN 60601-1-2
“Electromagnetic Compatibility - Medical Electrical Equipment”.
The system meets the requirements of EN 60601-1-2 (2001) Medical Electrical
Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard:
Electromagnetic compatibility — Requirements and tests.
Exceptions
Users should be aware of known RF sources, such as radio or TV stations and hand-
held or mobile two-way radios, and consider them when installing a medical device
or system.
Be aware that adding accessories or components, or modifying the medical device or
system may degrade the EMI performance. Consult with qualified personnel
regarding changes to the system configuration.
Radio and Telecommunication Terminal Equipment
Directive
The monitor contains a transmitter. The transmitter bears a CE mark indicating
conformity with the essential requirements specified in Article 3 of the Council
Directive 1999/5/EC of 9 March 1999 concerning Radio Equipment and
Telecommunications Terminal Equipment (R&TTE).
The essential requirements are as follows:
Article 3.1 (a) Health Safety; the product complies with the particular medical device
safety standards specified in the Medical Device Directive 93/42/EEC: EN 60601-1/
1990 + A1: 1993 + A2: 1995: Medical electrical equipment. General requirements for
safety.
Article 3.1 (b) EMC; the product complies with:
EN 60601-1-2 (2001) Medical electrical equipment: Part 1: General requirements
for safety - 2. Collateral standard: Electromagnetic compatibility - requirements
and test.
ETS 300 826 (1997): “Electromagnetic compatibility and Radio spectrum
Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for 2.4 GHz
Содержание Dash 3000
Страница 11: ...2000966 386D Dash 3000 4000 5000 ix Symbols F 8 ...
Страница 12: ...x Dash 3000 4000 5000 2000966 386D ...
Страница 15: ...2000966 386D Dash 3000 4000 5000 1 1 1 Introduction ...
Страница 33: ...2000966 386D Dash 3000 4000 5000 2 1 2 Equipment Overview ...
Страница 48: ...2 16 Dash 3000 4000 5000 2000966 386D Equipment Overview ...
Страница 49: ...2000966 386D Dash 3000 4000 5000 3 1 3 Monitor Setup ...
Страница 61: ...2000966 386D Dash 3000 4000 5000 4 1 4 Alarms ...
Страница 69: ...2000966 386D Dash 3000 4000 5000 5 1 5 Managing Patients ...
Страница 81: ...2000966 386D Dash 3000 4000 5000 6 1 6 Patient Data ...
Страница 92: ...6 12 Dash 3000 4000 5000 2000966 386D Patient Data ...
Страница 93: ...2000966 386D Dash 3000 4000 5000 7 1 7 Printing ...
Страница 97: ...2000966 386D Dash 3000 4000 5000 8 1 8 Monitoring ECG ...
Страница 116: ...8 20 Dash 3000 4000 5000 2000966 386D Monitoring ECG ...
Страница 117: ...2000966 386D Dash 3000 4000 5000 9 1 9 Monitoring Invasive Pressures ...
Страница 125: ...2000966 386D Dash 3000 4000 5000 10 1 10 Monitoring NBP ...
Страница 135: ...2000966 386D Dash 3000 4000 5000 11 1 11 Monitoring SpO2 ...
Страница 149: ...2000966 386D Dash 3000 4000 5000 12 1 12 Measuring Cardiac Output ...
Страница 155: ...2000966 386D Dash 3000 4000 5000 13 1 13 Monitoring Respiration ...
Страница 159: ...2000966 386D Dash 3000 4000 5000 14 1 14 Monitoring Temperature ...
Страница 162: ...14 4 Dash 3000 4000 5000 2000966 386D Monitoring Temperature ...
Страница 163: ...2000966 386D Dash 3000 4000 5000 15 1 15 Monitoring End Tidal CO2 ...
Страница 170: ...15 8 Dash 3000 4000 5000 2000966 386D Monitoring End Tidal CO2 ...
Страница 171: ...2000966 386D Dash 3000 4000 5000 16 1 16 Monitoring Anesthesia Gases ...
Страница 179: ...2000966 386D Dash 3000 4000 5000 17 1 17 Monitoring Impedance Cardiography ICG ...
Страница 185: ...2000966 386D Dash 3000 4000 5000 18 1 18 Monitoring Bispectral Index BIS ...
Страница 193: ...2000966 386D Dash 3000 4000 5000 A 1 A Maintenance ...
Страница 210: ...A 18 Dash 3000 4000 5000 2000966 386D Maintenance ...
Страница 211: ...2000966 386D Dash 3000 4000 5000 B 1 B Software Packages ...
Страница 214: ...B 4 Dash 3000 4000 5000 2000966 386D Software Packages ...
Страница 215: ...2000966 386D Dash 3000 4000 5000 C 1 C Factory Defaults ...
Страница 227: ...2000966 386D Dash 3000 4000 5000 D 1 D Custom Defaults ...
Страница 236: ...D 10 Dash 3000 4000 5000 2000966 386D Custom Defaults ...
Страница 237: ...2000966 386D Dash 3000 4000 5000 E 1 E Interfacing with Non GE Devices ...
Страница 255: ...2000966 386D Dash 3000 4000 5000 F 1 F Abbreviations and Symbols ...
Страница 268: ...Index 6 Dash 3000 4000 5000 2000966 386D ...
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